离子色谱法测定硫酸阿米卡星原料及其制剂的含量

Determination of Amikacin sulfate raw materials and its preparations by ion chromatography

目的采用离子色谱法测定硫酸阿米卡星原料及其制剂的含量。方法采用戴安Carbopac MA1(250 mm×4 mm)色谱柱,80 mmol.L-1氢氧化钠溶液为淋洗液,流速0.4 mL.min-1,柱温30℃,工作电极为1 mm金电极。结果硫酸阿米卡星与各杂质分离良好,1.7～80.4μg·mL-1硫酸阿米卡星与峰面积的线性关系良好(r=0.9998),其最低定量限为9 ng,最低检测限为3 ng,平均回收率为99.1%。结论所用方法准确、简便、灵敏,能有效控制硫酸阿米卡星原料及其制剂的质量。

OBJECTIVE To establish an ion chromatography method for determination of amikacin sulfate raw materials and its preparations.METHODS An Carbopac MA1（250 mm×4 mm） column was used with the eluent of 80 mmol·L-1 sodium hydroxide solution,the flow rate was 0.4 mL·min-1,and the column temperature was 30 ℃.Amperometric detector,working electrode was gold electrode（1 mm）.RESULTS The amikacin and the impurities could be separated.The linear range of amikacin was 1.7-80.4 μg·mL-1（r=0.9998）.The quantitative limit was 9 ng and the detection limit was 3 ng.The average recovery was 99.1%.CONCLUSION The method is accurate,simple,sensitive and suitable for quality control of amikacin raw materials and its preparations.